Medical Device Certified ISO13485 EMS OEM

China Wintech & Medical System Devices Equipments PCB assembly & Electronics Contract Manufacturing Outsources service with ISO certified 13485 Certification.

Wintech is an ISO 9001 & 13485 certified and FDA registered medical device contract manufacturing company. We have been a contract manufacturer of medical device for more than 20 years. We are committed to maintain full compliance in accordance with regulatory requirements.

For most of the cases, the medical device contract manufacturing is high-mix low-volume in nature. It requires adequate and skillful resource to carefully manage it. We have built a solid infrastructure and competent team to support the complexity and dynamic nature of the medical device contract manufacturing services.

With our continued commitment in high mix manufacturing, we have been well recognized as the vendor of choice by our customers. Quality, Speed, Responsiveness and Consistency are our specialty. We are a reliable partner you can always count on.

Best in Class Services:

We offer best in class Medical Device Contract Manufacturing Services to leading and also start-up medical OEM companies. We provide complete manufacturing services from PCB board assembly, box-build, testing & fulfillment services. For material sourcing and management services, we provide turnkey, consignment, and hybrid material solutions per customer requirements. We have earned great reputation through our high quality, on time delivery and responsive services.

Well planned & attention to details:

our project will be in good hand with us. Our proactive planning and attention to details, along with comprehensive engineering support and superior manufacturing technology help medical equipment customers quickly build quality prototype and NPI (New Product Introduction) on schedule. Significantly speed up the "Time-to-Market" for our customers.

Do it right the first time:

We offer pre-DFM to help customer's design engineers to correct any design issue before finalize their design for prototype build, our attention to details and our value-added engineering and manufacturing expertise help customers to do it right at the first time. We also provide post-DFM to further minimize any manufacturability issue for future volume production builds.

Leverage our buying power:

Our component engineer helps customer find alternative parts to solve lead time problem and also helps material cost down. Our procurement team can further help sourcing materials form suppliers for cost reduction.

Manufacturing Execution System (MES):

Wintech produces superior medical devices and equipments by implementing an integrated Manufacturing Execution System (MES). This MES software system along with the real time barcode data collection devices strengthens our quality control, and manages documentation for traceability and regulatory compliance. We can tailor the traceability system based on customer requirements.

Maintaining Medical Device History Records:

Wintech maintains medical device history records (DHR) in accordance with the requirements of the FDA regulations. Wintech Quality System ensures that DHR's are maintained in accordance with the Device Master Record (DMR).

Wintech provides responsive local quick-turn prototyping, NPI services and low-to-medium production and mass productions, helps you achieve faster "Time-to-Market".

A broad Range Of Medical System Products Experience:

Wintech produces a broad range of laboratory and point of use blood diagnostics, molecular diagnostics, blood separation and handling equipment. We build and manufacture ultrasound systems, CT, MR, nuclear medicine systems, X-Ray systems, patient monitors and medical devices. For over 20 years, Wintech has been producing high volume consumer medical and disposable medical devices.

Volume Production Experienced products as below:

• Family health medical

• Ultrosound imaging systerms

• X-Ray Systems

• Urological Therapy Systems Repair

• Semi conductor test equipment with mixed signal

• Relief Band for Motion Sickness and Pregnancy

• Patient Monitoring Systems

• Infusion Pumps

• Infrared Forehead Thermometer Gun

• Intelligent inspection robots

• Infrard thermal imager and camera

• intelligent infrared thermal image imaging temperature screening system solution

• infrared temperature measurement scanner

• Industrial controls

• Immunoassay diagnostic equipment

• Hematology equipment

• Enteral pumps

• Blood Glucose Meter

• Breast Biopsy Systems Repair

• Automated meter reading devices